HomeBelgiumMaterialise NV

Materialise NV

Belgium · Leuven · www.materialise.com
✓ Record-verifiedregistrations found in 10 marketsEU SRN BE-MF-000000034

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
112UDI-DI device records
Class I 4Class IIa 62Class IIb 46
USUnited StatesFDA openFDA
18listed device types
Class I 2Class II 16Class III 0
plus 46 registration records and 61 510(k)
UKUnited KingdomMHRA PARD
51registered device records
Class I 6Class IIa 20Class IIb 11Class III 4Custom-made 1Custom-made - Class I 2Custom-made - Class III 3Custom-made - Class IIa 3Custom-made - Class IIb 1
BRBrazilANVISA
5registered devices
Class I 1Class II 4
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class II 1
14 including historic records
TWTaiwanTFDA
3valid device licences
Class II 3
SGSingaporeHSA SMDR
4device registrations
CLASS B 4
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
18active ARTG entries
Class I 2IIa 10IIb 5Class Im (measuring) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union117 raw hits, 5 excluded, 112 confirmed
United States46 registration records, 61 510(k), 0 PMA, 7 excluded
United Kingdom51 confirmed, 1 excluded
Brazil5 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: Materialise Sdn Bhd · MATERIALISE N.V. · Materialise NV · MATERIALISE NV

Regulatory identity

EU manufacturer SRN
BE-MF-000000034
UK responsible person
Meridian Technique LTD

Company information

Country
Belgium
City
Leuven
Website
www.materialise.com
Product categories
Manufacturing, Lifecycle & Obsolescence ManagementManufacturing TypesAdditive ManufacturingAdditively Manufactured Components

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
MATERIALISE
LEI
5493004CXYDPCZ5RQK28
Registration status
Active
Legal form
Aktiengesellschaft (AG)
Incorporated
1990-06-28
Registered address
Technologielaan 15, Leuven, 3001
Registration authority
Crossroad Bank of Enterprises, no. 0441131254
Registry record updated
2025-12-02

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12004
22006
22008
12009
12010
52011
72012
12013
42014
22015
22016
62017
42018
32019
22020
42022
32023
42024
22025
42026

FDA listed device types

showing 8 of 18
System, Image Processing, Radiological 1Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Driver, Wire, And Bone Drill, Manual 1Plate, Bone 1Shoulder Arthroplasty Implantation System 1Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer 1Cranial Surgical Planning And Instrument Guides 1Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer 1

Registration details (sample)

MarketIdentifierNameClass / date
EU05420060344794Materialise SplintsClass I
EU05420060344169Materialise SplintsClass I
EU05420060345210Materialise SplintsClass I
EU05420060345203Materialise SplintsClass I
UK50484Mimics Enlight CMFClass IIa
UK50484Mimics Cardiac PlannerClass IIa
UK504843-maticClass I
USK260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner2026-06-09
USK251964Mimics Thoracic Planner2026-03-12
USK253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models2026-01-07
BR80117580949MIMICS MEDICALClass II
BR80117580937MATERIALISE PROPLAN CMFClass II
BR80117581157SurgiCase Shoulder PlannerClass II
CA93521SURGICASE CONNECTClass II

Similar companies

CemInnoFab Tic.Ltd.Sti.
Türkiye · markets 0
Ernst Rittinghaus GmbH
Germany · markets 0
EXSTO SAS
France · markets 0
Kläger Spritzguss GmbH & Co. KG
Germany · markets 0
ONOX MTT CO., LTD.
Japan · markets 0
Sinto Advanced Ceramics Europe GmbH
Germany · markets 1
Is this your company? Claim the page, add information or report a data error.Claim / report an error →